A Study Evaluating if Pridopidine is Safe, Efficacious, and Tolerable in Patients With Huntington's Disease (Open PRIDE-HD)
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|ClinicalTrials.gov Identifier: NCT02494778|
Recruitment Status : Terminated (This study served its purpose in providing considerable safety data.)
First Posted : July 10, 2015
Results First Posted : September 17, 2021
Last Update Posted : September 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Huntington's Disease||Drug: Pridopidine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||248 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Pridopidine in Patients With Huntington's Disease (Open PRIDE-HD)|
|Actual Study Start Date :||September 24, 2015|
|Actual Primary Completion Date :||January 12, 2018|
|Actual Study Completion Date :||January 12, 2018|
The mode of administration is oral. Capsules will be swallowed whole with water. One capsule should be taken in the morning and 1 in the afternoon, 7 to 10 hours after the morning dose. Study drug can be taken irrespective of meals.
45 mg BID
Other Name: TV7820
- Percentage of Participants With Adverse Events [ Time Frame: 106 weeks ]From signature of the informed consent form through the end of the study, which was defined as Week 106
- Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Inter-Onset-interval-SD-Hand [ Time Frame: Week 52; end of treatment (EOT) which was planned to occur at Week 104 ]Q-motor assessments were based on the application of force transducers and 3-dimensional position sensors. The reported parameter is the Pro-Sup-Inter-Onset-interval-SD-Hand, measured in seconds. Positive change from baseline indicates worsening.
- Change From Baseline in Quantitative Motor (Q-motor) Measurements, Pro-Sup-Peak-Force-CV-Hand [ Time Frame: Week 52; end of treatment (EOT) which was planned to occur at Week 104 ]Q-motor assessments were based on the application of force transducers and 3-dimensional position sensors. The reported parameter is the Pro-Sup-Peak-Force-CV-Hand, measured in %. Positive change from baseline indicates worsening.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494778
|Study Director:||Teva Medical Expert, MD||Teva Pharmaceuticals USA|